The present invention is directed to relatively stable, convenient and patient-friendly compositions of fenugreek seed extract, including pharmaceutically acceptable compositions thereof. The invention further provides a method for preparing such compositions. The compositions of this invention are advantageously used in methods for treating a non-diabetic individual having a disorder associated with high cholesterol. Specifically, the present invention includes employing fenugreek seed extract, or compositions or formulations comprising them, to lower cholesterol in a non-diabetic to a greater degree compared to conventional preparations. Fenugreek seed extracts, or compositions or formulations comprising them, have several advantages, including: the capability of daily oral dosing, ease of use in suspension form, safety, efficacy, purity, relative stability, and resuspendability over a short period of time.
The invention relates to an extraction process that uses fenugreek, fenugreek extracts or grinds (herein referred to as “juice” or “extract”). The instant compositions also encompass carbonated or non-carbonated beverages and formulations containing the aforementioned fenugreek extract which may further contain minerals, vitamins, nutrients, standard excipients, carriers, physiologically active agents, etc. The formulation may be in a ready-to-drink form in a container, a concentrate, or as a powder mix to be reconstituted with water or other ingestible liquids. Moreover, it may be compounded in the form of a pill, capsule, granules, microparticles, nanoparticles or liposomes.
The instant inventors have discovered that treating non-diabetic patients suffering from high cholesterol levels with the above-mentioned composition(s) significantly lowers the patient's cholesterol levels. While it may be anticipated that any soluble fiber may achieve a decrease in the blood cholesterol level (U.S. Pat. Nos. 4,834,990, 5,009,819, 5,558,897 and 5,851,578, incorporated herein by reference), the instant process yields the following unexpected result. While the prior art generally discloses a reduction of several points using “juices” such as those of fenugreek often in the range of 5-15 points (which is in the general range of 2-10%), the inventors compositions(s) derived via the specific extraction process yields invariably reductions in the range of 30% or higher (Table 1). For instance, consuming little amounts of fenugreek “juice” over thirty days of consecutive usage provides dramatic results enumerated herein. This data is unprecedented in the literature. In fact, such a result is neither disclosed in the prior art nor would it be obvious to one of ordinary skill in the art.
As stated above, the present invention also provides a ready-to-drink beverage or a concentrate in a solid (e.g., powder mix) or a liquid form for reconstitution into a beverage. Furthermore, such beverages may be supplemented with soluble minerals (e.g., calcium), vitamins, soluble fibers, flavors, colors, adjuvants, taste-masking agents, conventional solvents and carriers.
Commercially marketed fiber-containing products are not often well received by patients with respect to taste and appearance of the final product at the time of consumption. The present invention alleviates these problems.
The present invention also has the advantage of simplicity of extraction. The present inventors have discovered that simply boiling fenugreek seeds in water results in an extraction (the “juice” or “extract”) that can be directly employed in the claimed compositions to lower cholesterol to the specified degree.
Furthermore, the instant inventors have also noted the following benefits of using fenugreek “juice” (without any observed side effects):    1) alleviation of a woman's birth pains;    2) aiding women suffering from a lack of estrogen;    3) regulating menstrual period;    4) assisting in milk production in nursing women;    5) treating rheumatism;    6) treating cough and sore throat pain; and    7) acting as a sexual stimulant in women.
TABLE 1CholesterolCholesterolCholesterollevelslevelslevelsCholesterolfollowingfollowing threefollowinglevels priorone monthmonths ofone year ofto fenugreekof fenugreekfenugreekfenugreektreatmenttreatment%treatment%treatment%Case #AgeSex(mg/100 ml)(mg/100 ml)Decrease(mg/100 ml)Decrease(mg/100 ml)Decrease133M32028012.52402519040.6241M28022021.418035.715046.4348M330280152402718045.5457M28525510.521524.620528.1552M33724527.320040.716551644M29526510.221527.119833748M305285725516.420433.1839M44038013.628535.220553.4965M27624511.220525.715543.81058M28823817.422023.621027.11148M30524519.718539.317542.61247M2652457.523511.321518.91355M2762663.62605.823514.91462M4573522332030265421527M30526513.125516.421031.11655M33029012.126021.119939.71725M3452452923532225351836M2942302221029189361947M2822521122221.318534.42032M28823219.421027.115546.22153M2702351321520.4195282260M28423517.31853517538.42361M2952451721527.120032.22433M34024029.420041.2192442522M29021027.619034.518237.22642M28725511.122023.318535.52760M2902658.624017.218536.22858M2802703.623017.922021.42940M27524510.92202018532.73032M45538016.529036.322051.63145M29522025.419035.617042.43243M2702459.321022.2200263324M2902658.621027.619532.83447M29024515.520529.317539.73545M29726510.82202620032.73651M33028513.624525.8199403747M2802102520028.6185403878M29523520.321527.119334.63941M26021019.220023.1185294029M29923621.120531.519833.84116M33528519.82203819545.14246M29825614.122524.520531.24324M27022516.720524200264445M26021517.31952518030.84541M2502101620020190244655M2702459.321520.419527.84728M28025010.72102520028.64822M3102906.524520.919836.14935M2952900310029505048M3453550340034805155M2952980290031005245M2802800275028505338F3903201826033.3230415441F35528021.12203818547.95542F45035022.232028.923048.95647F2902706.922024.117539.75755F42537511.832523.524043.55845F33528514.926520.918544.85943F29622125.318537.515547.66035F2702459.220524.114546.36132F26520522.716537.711058.56231F2601952517532.713548.16337F24519520.415536.7125496435F28024014.319231.418035.76549F28522022.821026.320528.16656F29521527.120530.518537.36741F26821021.619626.914545.96846F29525513.619533.919035.66959F27824412.221522.720227.37055F24518524.515536.713544.97150F56049511.643222.929846.87266F33228514.223429.520039.87344F26022015.41952516536.57459F29024017.219532.816543.17537F30520532.817542.615549.27669F29526510.221028.820032.27755F2752557.321521.819529.17824F29023020.719831.717041.47947F31026514.52452120035.58048F27021022.219029.618033.38138F31025517.72202918540.38257F27721024.218533.2155448233F28824514.919831.318535.88468F28020028.619231.416541.18544F28525510.521026.319531.68637F27522518.220525.517337.18782F31025517.722527.419636.88875F28625510.821026.620030.18953F26521020.819526.419028.39042F2802558.922021.420028.69147F29124017.521027.8195339277F29526510.222523.719533.99344F288265823518.421525.39448F35028518.623532.920042.99552F28523517.520029.817538.69639F27524510.921521.820027.39757F26521020.820024.518030.19828F2852850275029009962F315310032003050